Posted by Michael Wonder on 28 Jun 2021
InnoCare announces breakthrough therapy designation of orelabrutinib by US FDA for treatment of relapsed or refractory mantle cell lymphoma
28 June 2021 - InnoCare Pharma announced today that the U.S. FDA has granted breakthrough therapy designation to its Bruton's tyrosine kinase inhibitor orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma.
Orelabrutinib is a highly selective Bruton's tyrosine kinase inhibitor targeting both B-cell malignancy and auto-immune diseases.
On 25 December 2020, orelabrutinib was approved by the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukaemia/small lymphocytic lymphoma and the treatment of patients with relapsed or refractory mantle cell lymphoma
